INVITED SESSION 6: Bayesian Methods in Clinical Development
Tracks
PLENARY HALL (Friends of Music))
| Wednesday, July 24, 2024 |
| 9:00 AM - 10:40 AM |
| PLENARY HALL (M1 building upper floor) |
Details
Since a few years, Bayesian methods have increasingly been proposed in clinical development, with a focus on paediatric investigations. This trend is mirrored in recent and upcoming guidance by international regulators such as the draft ICH E11A guideline on paediatric extrapolation (published for public consultation in 2022), the ICH E20 guideline on adaptive clinical trials (intended to be inalized in 2025) and an EMA concept paper on Bayesian methods in clinical development (intended to be published in 2024).
During this session, speakers from academia, the pharmaceutical industry, and regulatory authorities will share their perspective on the role of Bayesian methods in clinical development. The talks will cover novel and more established Bayesian methods as well as their application in the context of drug development. Such applications include the incorporation of external data through borrowing of information between adults and paediatric populations or between subgroups. The talks will highlight key methodological considerations as well as perceived benefits and challenges.
Presentations
Dr. Rebecca Turner
University College London, MRC Clinical Trials Unit
Dr. Nicky Best
VP, Statistics & Data Science Innovation Hub
GSK, London, United Kingdom
Dr. Andrew Thomson
European Medicines Agency (EMA)
Chair
Marcia Rückbeil
European Medicines Agency
